prequalification of quality control laboratories who quality monitoring

Prequalification of Prequalification of Quality Control LaboratoriesQuality Control Laboratories

WHO Quality MonitoringWHO Quality Monitoring

Jitka SabartovaWHO Prequalification of Medicines Programme

WHO/UNICEF Technical Briefing Seminar1 Nov 2012, Geneva

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WHO/UNICEF TBS, Geneva, 1 Nov 2012WHO/UNICEF TBS, Geneva, 1 Nov 2012

QCLs Prequalification Procedure• Established in 2004 in cooperation with UN agencies

– Initially limited to QC laboratories in Africa

• 3rd EOI published in September 2007, without regional limits– http://www.who.int/prequal/info_applicants/eoi/EOI-QCLabsV3.pdf

• Participation of a QC laboratory is voluntary– Any laboratory (private or governmental) can participate– Currently free of charge

• Scope - chemical and microbiological testing (including LAL test) of medicines (vaccines, biologicals not included)

• Priority in the assessment is given to– National QC laboratories and laboratories providing testing services

to the governments– QC laboratories in areas where UN agencies identify the need for

quality testing

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Prequalified / interested laboratories(September 2012) Prequalified QCLs:

South Africa, RIIP+CENQAM (2005) Algeria, LNCPP (2005) South Africa, Adcock Ingram (2007) Morocco, LNCM (2008) Kenya, NQCL (2008) India, Vimta Labs (2008) France, CHMP (2008) Vietnam, NIDQC (2008) Kenya, MEDS (2009) Singapore, TÜV (2009) Canada, K.A.B.S. Laboratories

(2010) Ukraine, CLQCM (2010) Ukraine, LPA (2010) Peru, CNCC (2010) Uruguay, CCCM (2010) Bolivia CONCAMYT (2010) Tanzania, TFDA (2011) India, SGS (2011) Belgium, SGS (2011) Netherlands, Proxy (2011) Portugal, INFARMED (2011) Brazil, FUNED (2011) Russia, FSBI-SCEEMP (2012) Belarus, RCAL (2012)

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QCLs in the procedure(September 2012)

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Capacity building

• Technical assistance provided to national medicines QCLs in developing countries– 18 since 2006 (6 in 2011, 4 in 2012)– Focus on implementation of quality system, microbiology testing

• Training– Training in dissolution and water determination (organized with AFSSAPS and

EDQM in September 2011, Senegal)

– Training for microbiological laboratories (November 2011, Jordan)

– Workshops on laboratory quality control of reproductive health products (organized with UNFPA in November-December 2011 - Tanzania and Namibia; February 2012 – Ghana; November 2012 – Thailand)

• External Quality Assessment Scheme for National Drug Quality Control Laboratories

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Potential benefits of PQ for QCLs

• Possibility to provide testing services to UN agencies and other organizations - financial profit

• Recognition as being WHO listed laboratory

• Facilitated discussions with manufacturers/customers in case of non-compliant results

• Learning process improving the standards of laboratory work

• In case on a national QCLs in a developing country, possibility to be assisted by WHO expert consultants and participate in WHO organized trainings

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Quality survey of antimalarials in AfricaQuality survey of antimalarials in Africa• Cooperation with NDRAs in Cameroon, Ethiopia, Ghana, Kenya, Nigeria, Tanzania• ACTs and sulfadoxine-pyrimethamine• 935 samples collected at all distribution levels including informal market

and screened by Minilab• 306 tested in laboratory according to Ph.Int., USP or laboratory method

32

44

0 0

27

56

8

0

63 67

0

17

0

10

20

30

40

50

60

70

Fai

lure

rat

e (%

)

ACTs SPs

Total failure = 28.5%

71.5%

16.9%

11.6% Compliant

Non-extremedeviations

Extremedeviations

• Failure for PQed products 4%• Failure for non PQed products 40%

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Quality survey of anti-TB medicines in NISQuality survey of anti-TB medicines in NIS• Cooperation with NDRAs in Armenia, Azerbaijan, Belarus, Kazakhstan, Ukraine, Uzbekistan

• Rifampicin, Isoniazid, Rifampicin/Isoniazid, Ofloxacin, Kanamycin

• 291 samples collected at hospitals, dispensaries, pharmacies and tested according to Ph.Int. or USP

• None of 38 samples of WHO-prequalified products failed

Total failure = 11.3%

88.7%

10.3%

1.0%

Compliant

Non-extremedeviations

Extremedeviations

10 107

23

4

13

0

5

10

15

20

25

Fai

lure

rat

e (%

)

Armenia

Azerbaijan

Belarus

Kazakhstan

Ukraine

Uzbekistan

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What should be kept in mind when organizing testing of procured medicines

• Considerations on necessity/frequency of testing based on risk evaluation– GMP compliance of the manufacturer, product prequalified or

registered by SRA

• Specifications for testing should be agreed with the supplier in advance– Manufacturer's specifications (with method transfer by the lab) or a

pharmacopoeia monograph

• Testing performed by a reliable laboratory– Out-of-specification results investigated by the lab– Discussion with the manufacturer– PQP should be informed about problems with PQed products

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Thanks for your Thanks for your attentionattention

[email protected]

[email protected]

www.who.int/prequal

prequalification of quality control laboratories who quality monitoring

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